Vascular device with valve for approximating vessel wall

ABSTRACT

A vascular device comprising a plurality of vessel engaging members and a valve. The device is movable from a collapsed insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter. The plurality of vessel engaging members extend outwardly from the device for securely engaging the internal wall of a vessel upon expansion of the device to the second expanded position, wherein the vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward a first expanded position having a third diameter greater than the first diameter and less than the second diameter. In the first expanded position the valve is movable between an open position to allow blood flow therethrough to a closed position to prevent blood flow.

[0001] This application claims priority from provisional patentapplication Serial No. 60/317,801, filed Sep. 7, 2001 and is acontinuation-in-part of U.S. patent application Ser. No. 09/877,639,filed Jun. 8, 2001, and a continuation-in-part of U.S. patentapplication Ser. No. 09/877,480, filed Jun. 8, 2001, both of which claimpriority from U.S. Provisional patent application No. 60/214,120, filedJun. 26, 2000. The entire contents of these four patent applications areincorporated herein by reference.

BACKGROUND

[0002] 1. Technical Field

[0003] This application relates to a vascular device and moreparticularly to a vascular device for approximating the vessel wall andplacing a valve for treating venous valve insufficiency.

[0004] 2. Background of Related Art

[0005] Veins in the body transport blood to the heart and arteries carryblood away from the heart. The veins have one-way valve structures inthe form of leaflets disposed annularly along the inside wall of thevein which open to permit blood flow toward the heart and close toprevent back flow. That is, when blood flows through the vein, thepressure forces the valve leaflets apart as they flex in the directionof blood flow and move towards the inside wall of the vessel, creatingan opening therebetween for blood flow. The leaflets, however, do notnormally bend in the opposite direction and therefore return to a closedposition to prevent blood flow in the opposite, i.e. retrograde,direction after the pressure is relieved. The leaflet structures, whenfunctioning properly, extend radially inwardly toward one another suchthat the tips contact each other to block backflow of blood.

[0006] In the condition of venous valve insufficiency, the valveleaflets do not function properly as they thicken and lose flexibility,resulting in their inability to extend sufficiently radially inwardly toenable their tips to come into sufficient contact with each other toprevent retrograde blood flow. The retrograde blood flow causes thebuildup of hydrostatic pressure on the residual valves and the weight ofthe blood dilates the wall of the vessel. Such retrograde blood flow,commonly referred to as reflux, leads to swelling and varicose veins,causing great discomfort and pain to the patient. Such retrograde bloodflow, if left untreated can also cause venous stasis ulcers of the skinand subcutaneous tissue. There are generally two types of venous valveinsufficiency: primary and secondary. Primary venous valve insufficiencyis typically a condition from birth, where the vein is simply too largein relation to the leaflets so that the leaflets cannot come intoadequate contact to prevent backflow. More common is secondary venousvalve insufficiency which is caused by clots which gel and scar, therebychanging the configuration of the leaflets, i.e. thickening the leafletscreating a “stub-like” configuration. Venous valve insufficiency canoccur in the superficial venous system, such as the saphenous veins inthe leg, or in the deep venous system, such as the femoral and poplitealveins extending along the back of the knee to the groin.

[0007] A common method of treatment of venous valve insufficiency isplacement of an elastic stocking around the patient's leg to applyexternal pressure to the vein, forcing the walls radially inwardly toforce the leaflets into apposition. Although sometimes successful, thetight stocking is quite uncomfortable, especially in warm weather, asthe stocking must be constantly worn to keep the leaflets in apposition.The elastic stocking also affects the patient's physical appearance,thereby potentially having an adverse psychological affect. Thisphysical and/or psychological discomfort sometimes results in thepatient remove the stocking, thereby preventing adequate treatment.

[0008] Another method of treatment has been developed to avoid thediscomfort of the stocking. This method involves major surgery requiringthe implantation of a cuff internally of the body, directly around thevein. This surgery requires a large incision, resulting in a longpatient recovery time, scarring and carries the risks, e.g. anesthesia,inherent with surgery.

[0009] Another invasive method of surgery involves selective repairingof the valve leaflets, referred to as valvuloplasty. In one method,sutures are utilized to bring the free edges of the valve cusp intocontact. This procedure is complicated and has the same disadvantages ofthe major surgery described above.

[0010] Co-pending, commonly assigned U.S. patent application Ser. Nos.09/877,639 and 09/877,480, incorporated herein by reference, disclose anadvantageous method and device to minimally invasively treat venousvalve insufficiency without requiring an outer stocking or internalcuff. Such device avoids the physical and psychological discomfort of anexternal stocking as well as avoids the risk, complexity and expense ofsurgically implanted cuffs. The device is advantageously insertedminimally invasively, i.e. intravascularly, and functions to effectivelybring the valve leaflets into apposition. This device first expandsagainst the vessel wall to grasp the wall, and then contracts to bringthe vessel wall radially inwardly so the leaflets can be pulled closertogether to a functional position. The present application utilizes thedevice of these prior applications for bringing the vessel wall radiallyinwardly to correct the dilation of the wall, but rather than rely onthe patient's existing valve leaflets which may be scarred ornon-functional, contains a replacement valve as a substitute for thepatient's leaflets. Thus, advantageously, venous valve insufficiency canbe treated minimally invasively by bringing the vessel wall inwardly andreplacing the patient's valve.

SUMMARY

[0011] The present invention provides a vascular device comprising aplurality of vessel engaging members and a valve. The device is movablefrom a collapsed insertion position having a first diameter to a secondexpanded position having a second diameter larger than the firstdiameter. The plurality of vessel engaging members extend outwardly fromthe device for securely engaging the internal wall of a vessel uponexpansion of the device to the second expanded position, wherein thevessel engaging members pull the internal wall of the vessel radiallyinwardly upon movement of the device from the second expanded positiontoward a first expanded position having a third diameter. This thirddiameter is greater than the first diameter and less than the seconddiameter. In the first expanded position the valve is movable between anopen position to allow blood flow therethrough to a closed position toprevent blood flow.

[0012] The device is preferably composed of shape memory material andpreferably the first expanded position substantially corresponds to thememorized position of the device. The device is expanded to the secondexpanded position by an expandable device, such as a balloon, positionedwithin the device.

[0013] In one embodiment, the device is initially movable from thecollapsed position to the first expanded position in response toexposure to body temperature, and is subsequently moved from the firstexpanded position to the second expanded position by an expandablemember. In another embodiment, the device is movable from the collapsedposition to the second expanded position by the substantial simultaneousexposure to body temperature and expansion by an expandable member.

[0014] The present invention also provides a vascular system comprisinga balloon catheter having an elongated shaft and an expandable balloon,a vascular device mounted over the expandable balloon and having a firstposition and a second expanded position, and a valve connected to thevascular device and movable between a closed position to prevent bloodflow and an open position to allow blood flow therethrough. The vasculardevice is expandable to the expanded position to engage the vessel wallsand returnable substantially to the first position to bring the wallsradially inwardly.

[0015] The vascular device in one embodiment comprises a shape memorymaterial and can be expandable first to a memorized condition inresponse to exposure to body temperature and subsequently expanded tothe expanded position by inflation of the balloon. Alternatively, thevascular device can be expandable to the expanded position as the deviceis substantially simultaneously exposed to body temperature and theballoon is inflated. The device in another embodiment can be composed ofstainless steel and is expandable by the balloon below its elastic limitto enable return of the device to the first position.

[0016] In the foregoing devices and system, the vascular device can bereleasably connected to the balloon. The valve can be attached to adistal end of the vascular device to extend downstream of the devicewhen positioned within a patient. Alternatively, the valve can beattached to a proximal end of the vascular device to extend within acentral portion of the device when positioned within a patient. Thevalve is preferably substantially conical in shape. The valve canalternatively have a duckbill valve configuration. In one embodiment, alongitudinal axis of the valve is offset from a longitudinal axis of thevascular device. The valve may include a plurality of blood drainageopenings extending through a side wall. A reinforcement ring can beprovided adjacent the distal opening.

[0017] The present invention also provides a method for treating venousvalve insufficiency comprising:

[0018] inserting a delivery device and a vascular device having areplacement valve into a target vessel adjacent the region of theremoved portion of leaflets;

[0019] deploying the vascular device to an enlarged diameter to securelyengage the internal wall of the vessel; and

[0020] reducing the diameter of the vascular device to move the vesselwall radially inwardly to reduce dilation of the vessel and implant thereplacement valve.

[0021] The method can further include the step of removing at least aportion of vein valve leaflets of a patient before inserting thevascular device.

[0022] In one embodiment, the method further comprises the step ofdeploying the vascular device to a first expanded diameter prior todeploying the device to the enlarged diameter, the first expandeddiameter being less than the enlarged diameter, and the step of reducingthe diameter of the vascular device returns the device to a diametersubstantially equal to the first expanded diameter. In this embodiment,the step of deploying the vascular device to a first diameter preferablycomprises the step of exposing the vascular device from a sheath of thedelivery device to enable the vascular device to return a shapememorized configuration in response to being warmed by body temperature.The step of the deploying the vascular device to an enlarged diameter inthis embodiment preferably includes the step of inflating a balloonpositioned within the device.

[0023] Alternatively the step of deploying the vascular device to anenlarged diameter comprises releasing the vascular device from thedelivery device to enable it to return to a shape memorized conditionand substantially simultaneously inflating a balloon.

[0024] The delivery device can be inserted through the jugular vein orfemoral vein into the popliteal vein or the saphenous vein.

Replacement Valve

[0025] In another aspect, the present invention provides a replacementvalve comprising a support structure and a valve attached thereto, thevalve being substantially conical in configuration and having a distalopening facing away from the longitudinal axis when the valve is in theclosed position and aligned with the longitudinal axis when the valve isin the open position.

[0026] In one embodiment the valve is attached to a proximal end of thesupport structure, and in another embodiment the valve is attached to adistal end of the support structure. In one embodiment, the valve isoffset with respect to the longitudinal axis of the support structure.The valve can optionally include a plurality of drainage openings formedin a side wall adjacent the proximal end.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Preferred embodiment(s) of the present disclosure are describedherein with reference to the drawings wherein:

[0028]FIG. 1 is a perspective view of a first embodiment of the vasculardevice of the present invention shown in the expanded configuration;

[0029]FIG. 2 is a side view of the vascular device of FIG. 1 in theexpanded configuration;

[0030]FIG. 3 is another side view of the vascular device in the expandedconfiguration, rotated 45 degrees with respect to FIG. 2;

[0031]FIG. 4 is a front view of the vascular device of FIG. 1 in theexpanded configuration;

[0032]FIG. 5 is a perspective view of the vascular device of FIG. 1shown in the collapsed configuration for delivery within the vessel;

[0033]FIG. 6 is a side view of the vascular device of FIG. 1 in thecollapsed configuration;

[0034]FIG. 7 is another side view of the vascular device in thecollapsed configuration, rotated 45 degrees with respect to FIG. 6;

[0035]FIG. 8 is a perspective view of an alternate embodiment of thevascular device of the present invention shown in the expandedconfiguration;

[0036]FIG. 9A is a side view of the vascular device of FIG. 8 shown inthe expanded configuration;

[0037]FIG. 9B is a side view similar to FIG. 9A except showing analternate embodiment where the vessel engaging members extend at anangle into the vessel wall;

[0038]FIG. 10 is a perspective view of the vascular device of FIG. 8 inthe collapsed configuration for delivery within the vessel;

[0039]FIG. 11 is a side view of the vascular device of FIG. 8 in thecollapsed configuration;

[0040]FIG. 12 illustrates one method of insertion of the vascular deviceof FIG. 1 showing the delivery catheter inserted directly into thepopliteal vein in an antegrade direction;

[0041]FIG. 13 illustrates an alternate method of insertion of thevascular device of FIG. 1 through the jugular vein for retrogradeinsertion into the popliteal vein;

[0042]FIG. 14 illustrates another method of insertion of the vasculardevice of FIG. 1 showing the delivery catheter inserted through theright femoral vein for retrograde access to the popliteal vein;

[0043]FIG. 15 illustrates yet another method of insertion of thevascular device of FIG. 1 showing a contralateral approach wherein thedelivery catheter is inserted through the left femoral vein foradvancement around the iliac vein for retrograde insertion into theright popliteal vein;

[0044]FIG. 16 shows a side view of the delivery catheter for thevascular device of FIG. 1, with the vessel wall shown in section,illustrating antegrade insertion of the delivery catheter in thepopliteal vein;

[0045]FIG. 17 is a view similar to FIG. 16 showing initial withdrawal ofthe sheath in the direction of the arrow to partially expose thevascular device of FIG. 1;

[0046]FIG. 18 is a view similar to FIG. 16 showing the vascular deviceof FIG. 1 expanded within the vessel, upstream (with respect to bloodflow) of the valve leaflets, after the sheath has been fully withdrawn;

[0047]FIG. 19 is a view similar to FIG. 16, showing the vascular deviceof FIG. 1 expanded by a balloon so the vessel engaging members penetrateand retain the vessel wall;

[0048]FIG. 20 is a view similar to FIG. 16, after the balloon isdeflated and the catheter withdrawn from the vessel, showing thevascular device returned to its original position pulling the vesselwall together and bringing the valve leaflets into apposition;

[0049] FIGS. 21A-21C are transverse cross-sectional views of thevascular device of FIG. 1 showing its interaction with the vessel wallduring delivery and placement, wherein

[0050]FIG. 21A corresponds to the initial position of the vasculardevice in FIG. 18 wherein the vessel engaging members have notpenetrated the vessel wall (the balloon has been omitted for clarity);

[0051]FIG. 21B corresponds to the position of the vascular device inFIG. 19 wherein the balloon has been inflated to radially expand thedevice to a second expanded position to enable the vessel engagingmembers to penetrate the vessel wall; and

[0052]FIG. 21C corresponds to the position of the vascular device inFIG. 20 wherein the balloon has been deflated and the device returns tothe first expanded position bringing the vessel wall radially inwardly;

[0053]FIG. 22 shows a side view of the delivery device for the vasculardevice of FIG. 1, with the vessel wall shown in section, illustrating asan alternative, retrograde insertion of the delivery device in thepopliteal vein;

[0054]FIG. 23 is a view similar to FIG. 22 showing initial withdrawal ofthe sheath in the direction of the arrow to partially expose thevascular device of FIG. 1;

[0055]FIG. 24 is a view similar to FIG. 22 showing the vascular deviceof FIG. 1 expanded within the vessel, upstream of the valve leaflets,after the sheath has been fully withdrawn;

[0056]FIG. 25 is a view similar to FIG. 22, showing the vascular deviceof FIG. 1 expanded by a balloon so the vessel engaging members penetrateand retain the vessel wall;

[0057]FIG. 26 is a view similar to FIG. 22, after the balloon isdeflated and the catheter withdrawn from the vessel, showing thevascular device returned to its original position pulling the vesselwall together and bringing the valve leaflets into apposition;

[0058]FIG. 27 is a side view of an alternative embodiment of thevascular device in the expanded position shown within a vessel (thevessel wall is shown in section);

[0059]FIG. 28 is a view similar to FIG. 27 showing a balloon expandingthe vascular device so the hooks penetrate the vessel wall;

[0060]FIG. 29 is an enlarged view of the hook of the device of FIG. 27embedded in the vessel wall;

[0061]FIG. 30 shows a side view of the delivery catheter for thevascular device of FIG. 1, with the vessel wall shown in section,illustrating as another alternative, antegrade insertion of the deliverycatheter in the popliteal vein for positioning of the vascular devicedownstream of the valve leaflets;

[0062]FIG. 31 is a view similar to FIG. 30 showing initial withdrawal ofthe sheath in the direction of the arrow to partially expose thevascular device of FIG. 1;

[0063]FIG. 32 is a side view of an alternate embodiment of the deliverysystem of the present invention having a restraint, the view beingsimilar to FIG. 23 in showing the vascular device expanded within thevessel, upstream of the valve leaflets, after the sheath has beenwithdrawn;

[0064]FIG. 33 is a view similar to FIG. 32, showing the vascular deviceof FIG. 1 expanded by a balloon so the vessel engaging members penetrateand retain the vessel wall, and the restraint being severed by expansionof the balloon;

[0065]FIG. 34 is a transverse cross-sectional view of the vasculardevice of FIG. 1 with the restraint of FIG. 32 shown expanded to thememorized position substantially simultaneously with expansion of theballoon;

[0066]FIG. 35A is a perspective view of the vascular device of thepresent invention having a first embodiment of a replacement valveattached thereto, the device being shown in the expanded position andthe valve shown in the open position;

[0067]FIG. 35B is a side view of the vascular device of FIG. 35A in thecollapsed position;

[0068]FIG. 36A is a side view of the vascular device of FIG. 35A shownin the expanded position;

[0069]FIG. 36B is a side view of the vascular device similar to FIG. 36Aexcept showing the alternate embodiment of the vascular device havingangled vessel engaging members;

[0070]FIG. 37A is a transverse cross-sectional view of the vasculardevice of FIG. 36A;

[0071]FIG. 37B is a transverse cross-sectional view of the vasculardevice of FIG. 37A;

[0072]FIG. 38A is a perspective view of a second embodiment of thereplacement valve of the present invention shown in the closed positionto prevent blood flow therethrough, the vascular device being shownschematically;

[0073]FIG. 38B is perspective view of the valve of FIG. 38A in the openposition to enable blood flow;

[0074]FIG. 39A is a perspective view of a third embodiment of thereplacement valve of the present invention shown in the closed positionto prevent blood flow therethrough, the vascular device being shownschematically;

[0075]FIG. 39B is perspective view of the valve of FIG. 39A in the openposition to enable blood flow;

[0076]FIG. 40A is a perspective view of a fourth embodiment of thereplacement valve of the present invention shown in the closed positionto prevent blood flow therethrough, the vascular device being shownschematically;

[0077]FIG. 40B is perspective view showing the valve of FIG. 40A in theopen position to enable blood flow;

[0078]FIG. 41A is a perspective view of a fifth embodiment of thereplacement valve of the present invention having drainage slits formedtherein and shown in the closed position to prevent blood flowtherethrough, the vascular device being shown schematically;

[0079]FIG. 41B is perspective view showing the valve of FIG. 41A in theopen position to enable blood flow;

[0080]FIG. 42 is a perspective view of a sixth embodiment of thereplacement valve of the present invention, in the form of a duckbillvalve, shown in the closed position to prevent blood flow therethrough,the vascular device being shown schematically;

[0081]FIG. 43 is perspective view of the valve of FIG. 42 in the openposition to enable blood flow;

[0082]FIG. 44 is a top view of the valve of FIG. 42;

[0083]FIG. 45 is a schematic view of two vascular devices with theoffset valves of FIG. 41 inserted in the popliteal and femoral vein of apatient;

[0084] FIGS. 46A-46C illustrate sequentially the steps of insertion ofthe vascular device shown schematically with the offset valve of FIG. 41inserted into the popliteal vein wherein

[0085]FIG. 46A shows advancement of the delivery catheter and valvethrough introducer sheath;

[0086]FIG. 46B shows withdrawal of the pusher from the delivery catheterto release the vascular device;

[0087]FIG. 46C shows withdrawal of the delivery catheter for expansionand placement of the vascular device;

[0088] FIGS. 47A-47C illustrate sequentially the steps of inserting agrasper to reposition the vascular device wherein

[0089]FIG. 47A illustrates the grasper and outer tube inserted throughthe introducer sheath to access the vascular device;

[0090]FIG. 47B illustrates advancement of the prongs from the outer tubetowards the vascular device; and

[0091]FIG. 47C illustrates the vascular device grasped and movedproximally by the prongs to a different location;

[0092]FIG. 48A is a cross-sectional view of a seventh embodiment of thereplacement valve of the present invention having a reinforcementtherein, and shown positioned with a covered stent;

[0093]FIG. 48B is a perspective view of the replacement valve of FIG.48A, with a portion of the covered stent cut away, showing the valve inthe closed position;

[0094]FIG. 48C is a view similar to FIG. 48A except showing the valve inthe open position;

[0095]FIG. 49A is a top view of the vascular device and valve of FIG.48;

[0096]FIG. 49B is a cross-sectional view taking along lines B-B of FIG.49A;

[0097]FIG. 50 is perspective view of a first embodiment of a vasculardevice in the form of an expandable cylinder and having an eighthembodiment of the replacement valve attached thereto, the valve shown inthe closed position;

[0098]FIG. 51 is a perspective view of the valve of FIG. 50 in the openposition to enable blood flow;

[0099]FIG. 52 is a perspective view of the vascular device of FIG. 50having a ninth embodiment of a replacement valve attached thereto, thevalve shown in the open position;

[0100]FIG. 53 is a top view of the vascular device and valve of FIG. 52;

[0101]FIG. 54A is a bottom view of the vascular device of FIG. 52 shownin the expanded position;

[0102]FIG. 54B is a bottom view of the vascular device in FIG. 52 shownin the retracted position; and

[0103]FIG. 55 is a cross-sectional view of a tenth embodiment of areplacement valve in the form of an expandable cylinder having aduckbill valve.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0104] Referring now in detail to the drawings where like referencenumerals identify similar or like components throughout the severalviews, FIGS. 1-7 illustrate a first embodiment of the vascular device ofthe present invention and FIGS. 8-11 illustrate a second embodiment ofthe vascular device of the present invention. The devices, designatedgenerally by reference numerals 10 and 100, are expanded to engage theinternal wall of the vessel and contracted to pull the vessel wallsradially inwardly. By pulling the vessel wall radially inwardly, thevalve leaflets within the vessel are pulled closer together to afunctional condition.

[0105] FIGS. 1-4 illustrate vascular device 10 of the first embodimentin the expanded configuration and FIGS. 5-7 illustrate vascular device10 in the collapsed configuration. Vascular device 10 is preferablycomposed of a shape memory material, such as a nickel-titanium alloycommonly known as Nitinol, so that in its memorized configuration itassumes the shape shown in FIG. 1. This shape memory materialcharacteristically exhibits rigidity in the austenitic state and moreflexibility in the martensitic state. To facilitate passage from thedelivery catheter, the shape memory device is maintained in a collapsedconfiguration inside a delivery sheath as described in more detailbelow, where it is cooled by a saline solution to maintain the devicebelow its transition temperature. The cold saline maintains thetemperature dependent device in a relatively softer condition as it isin the martensitic state within the sheath. This facilitates the exit ofdevice 10 from the sheath as frictional contact between the device andthe inner wall of the sheath would otherwise occur if the device wasmaintained in a rigid, i.e. austenitic, condition. When the device 10 isreleased from the sheath to the target site, it is warmed by bodytemperature, thereby transitioning in response to this change intemperature to an austenitic expanded condition.

[0106] Device 10 is preferably formed from a tubular member, preferablyby laser cutting. Device 10 includes a proximal portion 12, andintermediate portion 14 and a distal portion 16. In the expandedcondition, the device 10 has four substantially diamond shaped cells 17forming substantially diamond shaped openings 18 at the proximal portion12 and four substantially diamond shaped cells 15 forming substantiallydiamond shaped openings 20 at the distal portion 16. The end regions 19of the cells 18, and the end regions 21 of the cells 20 are bentoutwardly from the plane of the remainder of the cell, in a directionaway from the longitudinal axis of the vascular device 10. This betterenables the vessel engaging members, described below, to engage thevessel walls.

[0107] The intermediate portion 14 is formed of four substantiallydiamond shaped cells forming substantially diamond shaped openings 22arranged around a 360 degree arc of the cylindrical tubular member 10,with a longitudinal strip 24 extending through to bisect each cell.Thus, four symmetric bisected cells 23 are formed. Each longitudinalstrip 24 has a vessel engaging member 28 extending therefrom to engagethe vessel wall as will be described below. In the expanded condition,the longitudinal strip 24 buckles radially outwardly, away from thelongitudinal axis of the vascular device 10, to enable the center vesselengaging members 28 (described below) to engage and secure the internalvessel wall.

[0108] The geometry of the vascular device 10 can also be appreciatedwith reference to the collapsed configuration of the vascular device 10shown in FIGS. 5-7. As shown, the device 10 is in the form of a cylinderwith a reduced diameter. Each longitudinal strip 24 has a cutout 27 toform vessel engaging member 28. The longitudinal strip 24 is tapered inwidth “w” at its opposing ends 29 which connect to the framework. Thelongitudinal slot 30 on each side of the strip 24 is substantiallystraight and has enlarged oval-like regions 32 at opposing ends. Theouter wall 34 of each longitudinal slot 30, i.e. the wall of slot 34spaced further from the longitudinal strip 24, is joined to the outerwall 34 of an adjacent longitudinal slot 30 by transverse rib 36. Eachrib 36 forms one vertex of a cell 15 and one vertex of a cell 17 whenexpanded. The cell openings 18 and 20 in the collapsed configuration asshown in FIG. 6, have, respectively, a narrowed elongated portion 20 a,18 a, and a widened portion 20 b, 18 b with flared out regions 20 c, 18c, to form the diamond shaped openings having bent end regions 21, 19when device 10 is expanded. The flared out regions 20 c, 18 c enable theformation of such bent regions 21, 19.

[0109] A vessel engaging member extends from the framework of each ofthe cells 15 and 17. The vessel engaging member is preferably in theform of a hook with a penetrating tip and a barb.

[0110] More specifically, a vessel engaging member 40 extends outwardlyand distally from the frame of each of the four cells 15 at the distalportion 16 of the device 10. In the collapsed configuration of device10, each member 40 preferably extends generally parallel to thelongitudinal axis of vascular device 10 and in substantially the sameplane as the corresponding rib 36 at the opposing end.

[0111] Similarly, vessel engaging members 42 extend outwardly andproximally from the framework of each of the four cells 17 at theproximal portion 12 of the device 10. In the collapsed configuration ofdevice 10, each member 42 preferably extends generally parallel to thelongitudinal axis of vascular device 10 and in the same plane as thecorresponding rib 36 at the opposing end

[0112] The four vessel engaging members 28 formed in the middle(intermediate) portion 14 in the collapsed configuration liesubstantially parallel the longitudinal axis of the device 10 and in thesame plane as the longitudinal strip 24 from which it is formed.

[0113] Each of the vessel engaging members 28, 40 and 42, are preferablyin the form of a hook having a penetrating tip 29, 41 and 43 to piercethe vessel wall and a barb 31, 45 and 47, respectively, to help retainthe vessel wall. The sharp penetrating tips 29, 41, 43 penetrate thevessel wall in a radial direction and hold the vessel against axialmovement with respect to the device 10; barbs 31, 45, 47, restrictradial movement of the vessel with respect to the device 10, therebytogether securely retaining (grasping) the vessel wall for radial inwardmovement described below.

[0114] It should be understood that although four vessel engagingmembers 42, 40, 28 are described extending from the proximal and distalcells 17, 15 and from the center longitudinal strips 24, respectively, afewer or greater number of vessel engaging members can be provided aslong as they achieve the vessel retaining function as described in moredetail below.

[0115] When the vascular device 10 expands, members 28, 40 and 42 aremoved to a shape memorized orientation bent outwardly at an angle,preferably about 90 degrees, with respect to the longitudinal axis “A”of the device 10 with regions 19 and 21 bending out of the plane toincrease the distance the members can extend from the center to thevessel wall. Longitudinal strips 24 buckle radially outwardly, andmembers 28 bend outwardly at an angle, preferably about 90 degrees, withrespect to the longitudinal axis, to engage the vessel wall. Although 90degree angles are shown, clearly other angles are contemplated. Notethat due to the geometry of the device 10, the points at the outer edgecome inwardly axially, shortening the length of the device, and thecenter strut (strip) 24 buckles radially outwardly. The buckling extendsthe radial reach of the device 10. Note also that in the expandedconfiguration, the tips of the vessel engaging members terminate atsubstantially the same distance from the longitudinal axis of the device10. The length of the end hooks is preferably the same as the length ofthe middle hooks; the bent regions 19, 21 accommodate for the bucklingof strut 24. Due to the laser cut configuration, foreshortening, i.e.the reduction in length of the device in response to expansion, isreduced.

[0116] By way of example, for use for instance in an unhealthy dilatedvessel of 14 mm the length of the vascular device 10 in the collapsedconfiguration could be about 3 cm and the outer diameter about 3.5 mm.In the memorized expanded configuration, the length decreases to about2.8 cm and the transverse cross-sectional dimension increases to about12 mm, 15.5 mm if the 1.7 mm hooks are included. Note that the lengthchange is due mostly to the buckling strip and the bent regions sincethe amount of foreshortening is minimized. These dimensions are providedby way of example as other dimensions are clearly contemplated by thepresent invention and use in different size vessels is alsocontemplated.

[0117] An alternate preferred embodiment of the vascular device of thepresent invention is shown in FIGS. 8-11, with FIGS. 8 and 9 showing thedevice in the expanded configuration and FIGS. 10-11 showing thecollapsed configuration for delivery to the vessel.

[0118] Turning first to FIGS. 10 and 11, the device 100 is preferablylaser cut from a cylindrical tube, forming a series, e.g. ten, ofsymmetrical longitudinal strips 102 terminating at opposite ends withvessel engaging members 110, 112. Each strip 102 has a longitudinal slot104 formed therein having a uniform width throughout its length.Adjacent strips 102 are joined by transverse ribs or struts 106,creating a gap 108, 109 on either side of the ribs 106 between strips102. Consequently, the device can be considered as forming one centrallylocated column of slots 104 with ribs 106 in axial alignment and slots104 in axial alignment.

[0119] The vessel engaging members 110 and 112 are preferably in theform of hooks as described above in the first embodiment with eachvessel engaging member 110 having a penetrating tip 114 and barb 116 andeach member 112 having a penetrating tip 118 and barb 119. Thepenetrating tips 114 and 118 penetrate the vessel wall and prevent axialmovement while the barbs 116, 119 restrict radial movement. In thecollapsed configuration, as shown, the vessel engaging members 110, 112are substantially parallel to the longitudinal axis of device 100, lyingin the same plane as the respective longitudinal strip 102.

[0120] As shown, the cylindrical tubular member is formed into tenlongitudinal strips 102 with ten hooks 110 at the proximal end 105 andten hooks 112 at the distal end 107. Although ten longitudinal stripsand ten vessel engaging members are shown on each end, it should beappreciated that fewer or greater number of longitudinal strips andvessel engaging members can be utilized. Moreover, not all of thelongitudinal strips need to terminate in vessel engaging members,provided a sufficient number of strips have vessel engaging members toadequately secure the vessel.

[0121] The structure of the vascular device 100 is shown in its firstexpanded configuration in FIGS. 8 and 9. Vascular device 100, likedevice 10, is composed of a shape memory material, such as Nitinol, sothat in its memorized configuration it assumes the shape shown in FIG.8. The shape memory device is maintained in a collapsed configurationinside a sheath as described in more detail below, where it is cooled bya saline solution to maintain the device below its transitiontemperature. When the device 100 is delivered to the target site andreleased from the sheath, it is warmed by body temperature, therebytransitioning in response to this change in temperature to an austeniticexpanded condition. Maintenance of the device in its softenedmartensitic state within the sheath facilitates delivery to the vesselas frictional contact between the device 100 and the internal walls ofthe delivery sheath would otherwise occur if the device was retainedwithin the sheath in its austenitic condition.

[0122] When expanded, longitudinal slots 104 form substantially diamondshaped cells 120 with substantially diamond shaped openings 122. Uponexpansion, the vessel engaging members 110 and 112 extend at an angle,preferably about 90 degrees, to the longitudinal axis of the vasculardevice 10 to enable the vessel engaging members 110 and 112 to engageand secure the vessel wall (see e.g. FIG. 9A). However, it is alsocontemplated that the vessel engaging members 110′, 112′ could extend ata different angle, for example about 60 degrees, as shown in thealternative embodiment of FIG. 9B.

[0123] As the device moves from the collapsed configuration to theexpanded configuration, it shortens in axial length as the diameterincreases. For example, in one embodiment the length of the vasculardevice 100 in the collapsed configuration is about 1.8 cm and thediameter is about 3.5 mm. In the expanded configuration, the lengthdecreases to about 1 cm, mainly due to the hooks bending up asforeshortening is minimized, and the diameter in the memorized expandedconfiguration increases to about 12 mm. (15.5 if the 1.75 mm hook lengthis included). These dimensions are provided by way of example as otherdimensions are clearly contemplated.

[0124] Turning to the method of use of the vascular devices of thepresent invention, the insertion of vascular device 10 will bedescribed, it being understood that vascular device 100 would beinserted in the same manner and expanded and retracted in the samemanner as device 10.

[0125] There are several different methods of insertion of the vasculardevice of the present invention for treating venous valve insufficiencyof the popliteal or saphenous vein. FIGS. 12-15 illustrate examples ofsome of these approaches by illustrating various access vessels for thedelivery devices to reach these veins. In FIG. 12, the catheter 200 isplaced into the popliteal vein “P” in the patient's leg “G” and advancedto a region adjacent the leaflets “T” to deploy the vascular deviceupstream of the leaflets. The delivery catheter is thus delivered in anantegrade fashion, with the tip extending downstream of leaflets “T” todeploy the device just upstream (defined in reference to the directionof blood flow) of the leaflets.

[0126] In the approach of FIG. 13, the catheter 210 is inserted throughthe right jugular vein “J”, where it will be advanced through thesuperior and inferior vena cava, past the iliac vein “I”, through thefemoral vein “F” and into the popliteal vein “P” through leaflets “L” ina retrograde fashion, i.e. opposite the direction of blood flow. Thedelivery catheter 210 would thus extend through the leaflet region justupstream of the leaflets. In FIG. 14, the catheter 220 is placed in theright femoral vein “F”, where it will be advanced in a retrograde mannerto the popliteal vein “P” in the manner described above with respect toFIG. 13.

[0127] In the contralateral approach of FIG. 15, the catheter 230 isinserted through the left femoral vein “H” where it will be advancedaround the iliac vein “I” and through the left femoral vein “F” into thepopliteal vein “P.”

[0128] Each of the delivery catheters 200, 210, 220 and 230 hasrespective tubing 202, 212, 222 and 232, with a stopcock 204, 214, 224and 234 to control saline infusion through the catheter to maintain thevascular device 10 (or device 100) in the cooled martensitic collapsedconfiguration for delivery. Inflation port 206, 216, 226 and 236provides for fluid infusion to inflate the balloon which is mounted onthe catheter shaft and positioned within the device 10. The outer sheathof the delivery catheter slides with respect to the catheter shaft toexpose the vascular device. Guidewire port 208, 218, 228 and 238 enablesinsertion of a conventional guidewire (not shown) to guide the deliverycatheter intravascularly to the target site. A conventional access orintroducer sheath (not shown) would be inserted through the skin andinto the access vessel, and the respective delivery catheter would beinserted into the access vessel through the introducer sheath.

[0129] FIGS. 16-20 illustrate the method steps of insertion of thevascular device 10 in an antegrade fashion intravascularly in thepopliteal vein “P”. Catheter or delivery sheath 200 is inserted over aconventional guidewire (not shown) so the distal tip 201 of the cathetershaft extends past, i.e. downstream of the valve leaflets L extendingannularly from vessel wall “V” as shown in FIG. 16. As can beappreciated, since there is a gap “a” between the valve leaflets “L”,the valve cannot function properly because the leaflets cannot properlyclose to prevent backflow. Also, due to the malfunctioning of the valve,the vessel wall becomes dilated as shown as the weight and pressure ofthe backflow blood pushes out the vessel wall.

[0130] Once the position of the sheath 200 is confirmed by venography,intravascular ultrasound, or other means, the sheath 205 is withdrawnwith respect to catheter tip 201 in the direction of the arrow of FIG.17, exposing the vascular device 10. When the sheath 205 has been fullywithdrawn to expose the device 10, the device is warmed by the bodytemperature and transitions to its austenitic phase and the firstmemorized expanded configuration of FIG. 18.

[0131] Next, a balloon member 240 on catheter shaft 209 which ispositioned within device 10 is inflated via introduction of fluidthrough inflation lumen 206 (FIG. 12) to further expand the device 10 toa second expanded configuration shown in FIG. 19. That is, the device isexpanded to a larger diameter than the diameter in its memorizedconfiguration of FIG. 18 so that vessel engaging members 28, 40 and 42will engage the vessel wall “V” with the sharp tips and barbspenetrating the vessel wall to firmly grasp and secure it. Thissecurement restricts both radial and axial movement of the vessel toenhance retention by the device 10.

[0132] After retention of the vessel wall as in FIG. 19, the balloon isdeflated (and the catheter 200 removed), resulting in the device 10contracting from the second expanded configuration towards its memorizedconfiguration. Preferably, the device 10 will return to substantiallythe same diameter as the first (memorized) expanded configuration. Ascontracted, the device 10, due to the engagement of the vessel engagingmembers with the internal wall of the vessel, pulls the vessel wallradially inwardly, thereby pulling the leaflets radially inwardly to theposition of FIG. 20 to close gap “a”. As can be appreciated, the vesselwall is no longer dilated and the valve leaflets are sufficientlyapproximated such that their tips contact to block backflow and theirfunction is therefore restored. The device 10 remains inside the vessel,maintaining the approximation of the vessel wall to maintain the properfunctioning of the leaflets.

[0133] The changing diameters of the vascular device 10 can also beappreciated by reference to the transverse cross-sectional views ofFIGS. 21A-21C. The delivery device has been removed for clarity. Morespecifically, FIG. 21A corresponds to the initial position of thevascular device 10 in FIG. 18 wherein the device 10 has been deliveredto the target vessel, and has expanded to the first expanded (memorized)configuration but the vessel engaging members have not penetrated thevessel wall. It should be appreciated that in this configuration thevessel engaging members may or may not be in contact with the vesselwall, but in either case, do not fully penetrate and secure the vesselto the same extent as in the second position. As shown, by way ofexample, the unhealthy dilated vessel can have an internal diameter D1of approximately 14 mm. The balloon is not shown in FIG. 21A forclarity.

[0134]FIG. 21B corresponds to the position of the vascular device inFIG. 19 wherein the balloon has been inflated to radially expand thedevice 10 to a second expanded position to enable the vessel engagingmembers to penetrate and retain (secure) the vessel wall. In thisconfiguration, the vessel wall is further expanded to a diameter D2 ofabout 16 mm, as the device is expanded to a diameter of about 16 mm,with the hooks extending an additional 2 mm so the device is expanded to20 mm.

[0135]FIG. 21C corresponds to the position of the vascular device 10 inFIG. 20 wherein the balloon has been deflated and the device contractedto bring the vessel wall radially inwardly. The internal vessel walldiameter will preferably be about 12 mm to close the gap between theleaflets. The diameter of the vascular device 10 preferably returns tothe same diameter as in FIG. 21A, e.g. about 12 mm. As can be seen thedevice 10 abuts the vessel wall V.

[0136] FIGS. 22-26 illustrate retrograde insertion of the vasculardevice 10. In this approach the delivery catheter, e.g. catheter 210, isinserted in a direction against the blood flow so tip 211 extends pastthe valve leaflets “L” in the popliteal vein “P” and the catheter 210 ispositioned so the device 10 will be deployed upstream of the leaflets.The deployment of the device 10 is otherwise the same as in FIGS. 16-20.That is, sheath 215 of the delivery device 210 is retracted in thedirection of the arrow of FIG. 23, to expose the device 10. Fullretraction and removal of the sheath 215 to expose the device to thewarmer body temperature enables it to expand to its memorized (firstexpanded) configuration of FIG. 24. Subsequent expansion of balloon 250(FIG. 25) causes the vessel engaging members 42, 28, 40 to penetrate andretain the vessel wall so that upon deflation of the balloon, the device10 returns to the memorized configuration of FIG. 26 pulling the vesselwall inwardly and bringing the valve leaflets “L” closer together intoapposition so the tips can contact. The changing diameters would alsocorrespond to the aforedescribed transverse cross-sections of FIGS.21A-21C.

[0137] As can be appreciated, device 10 and device 100 are eachsymmetrical so that the “proximal” and “distal” portions are identifiedherein for convenience.

[0138] FIGS. 27-29 illustrate an alternate embodiment of the vasculardevice designated generally by reference numeral 300. This shape memorydevice 300 is illustrated and described in Provisional patentapplication No. 60/214,120, filed Jun. 6, 2000, the entire contents ofwhich are incorporated herein by reference. Device 300 is placed withinvessel V, e.g. the popliteal vein, to approximate leaflets “L” which asshown in FIG. 27 are not functioning properly because the tips L1 arespaced apart. In its first expanded configuration corresponding to itsmemorized shape of FIG. 27, hooks 314 have not penetrated the vesselwall. The device 300 is formed by struts 302 as described in detail inthe '120 application. Hooks 314, affixed to struts 302 at region 304 arecrescent shaped and have pointed ends 306 with barbed portions 308.

[0139] In the expanded configuration of FIG. 28, balloon 322 on shaft324 of the delivery device has expanded the device 300 so that hooks 314penetrate and securely engage the vessel wall “V”. The balloon wouldthen be deflated and the device 300 would return to its first expandedconfiguration bringing the vessel walls radially inwardly and bringingthe valve leaflets into apposition in the same manner as described abovewith respect to vascular device 10.

[0140]FIGS. 30 and 31 illustrate an alternate method of placement of thevascular device. In this method, the vascular device 10 (or vasculardevice 100) is placed downstream (with respect to the direction of bloodflow) of the valve leaflets. The delivery catheter 210′ is inserted inthe same antegrade manner as described above with respect to FIG. 16,except it is advanced sufficiently past the valve leaflets L to enabledownstream delivery of the device 10. Once positioned as shown in FIG.31, the sheath 215′ is withdrawn in the direction of the arrow, enablingthe device 10 to expand to its memorized configuration. Vascular device10 would then be further expanded by a balloon and then enabled tocontract to its memorized configuration in the same manner as in FIGS.18-20, the only difference being that the device 10 would grasp thevessel wall downstream of the valve leaflets to pull the vessel wallradially inwardly to bring the leaflets into apposition.

[0141] It should be appreciated that the device 10 or device 100 couldalso be delivered in a retrograde fashion such as shown in FIGS. 13-15for positioning of the device downstream of the leaflets L.

[0142] FIGS. 32-34 illustrate an alternative delivery system and methodfor vascular device 10 (or device 100 which can be delivered in the samemanner). In this method, exposure of the vascular device to bodytemperature and expansion of the balloon occur substantiallysimultaneously. To facilitate placement, a restraint system forconnecting the vascular device to the balloon is provided.

[0143] More specifically, balloon 250′ has a pair of sutures 252attached thereto at a proximal and distal portion which wrap around thevascular device 10 forming a loop of suture to connect the balloon andthe device. Although two sutures, are shown, it is contemplated that onesuture or more than two sutures can be utilized to connect the balloon250′ to the vascular device 10. Additionally, other restraint systemssuch as perforated strips can be utilized.

[0144] In the position of FIG. 32, the sutures (only one of which isshown, the other suture still within the sheath 215′) are looselywrapped around the device. As the sheath 215′ is retracted in thedirection of the arrow, the balloon is inflated. Thus, as the sheath215′ is fully withdrawn, the device expands to the position of FIG. 33,without the intermediate step required in the methods described above,i.e. without the step of FIG. 24 which first allows the device to expandto the memorized configuration. As the balloon expands, the pressureagainst the sutures 252 breaks the suture loops, thereby releasing themfrom the vascular device 10. This way, when the balloon 250′ is deflatedand withdrawn with the delivery catheter 210′ from the body, the sutures252 are removed as well. Upon deflation, the vascular device 10 returnsto its memorized configuration to pull the vessel wall radially inwardlyin the manner described above to assume a position like that of FIG. 26.

[0145] Note that it is also contemplated that the balloon 250′ can beinflated first within the sheath, followed by withdrawal of the sheathto expose the vascular device 10 to body temperature.

[0146] Additionally, the restraint system can also be utilized with thesequential method of deployment of FIGS. 16-20 and FIGS. 22-26. Therestraint system, e.g. the sutures, would help prevent axial movementand help center the balloon with respect to the vascular device 10.Other restraint systems, such as a strap, could be used to releasablyconnect the vascular device to the balloon.

[0147] As an alternative to shape memory, a stainless steel or polymericvascular device. Such device would be expanded by a balloon below itselastic limit, thus enabling the device to return to its smallerconfiguration after the balloon is deflated. The vascular device couldalso be in the form of a braided structure which can be expanded toengage the vessel wall by squeezing or compressing its end(s), and thenreleasing it to enable it to return to its more elongated position ofreduced diameter to approximate the vessel wall.

Vascular Device with Replacement Valve

[0148] The foregoing embodiments of FIGS. 1-34 describe and showvascular devices which bring the vessel wall radially inwardly toapproximate the patient's existing valve leaflets of the patient. Inanother aspect of the present invention, instead of approximating thevalve leaflets, the vascular device inserted in the vessel has areplacement valve attached thereto. Thus, the vascular device isinserted to expand and contract as described above, bringing the dilatedvessel wall radially inwardly and leaving the replacement valve insidethe vessel attached to the implanted vascular device. This replacementvalve can be utilized as a total replacement wherein the patient's valveleaflets are removed, or can be placed upstream or downstream of thepatient's leaflets, leaving the nonfunctioning leaflets in place.Various embodiments of valve configurations used in conjunction withvascular devices are described in detail below and illustrated in FIGS.38-48. FIGS. 38-48, for simplicity, show the vascular deviceschematically, it being understood that any of the foregoing vasculardevices can be utilized with the various valve configurations. Thevalves can be attached at the proximal end, distal end, or intermediatethe proximal and distal ends of the vascular devices.

[0149] Turning first to FIGS. 35A-37, vascular device 400 issubstantially identical to vascular device 100 of FIG. 9A, except forthe provision of valve 450. For this reason, it has been labeled with adifferent reference numeral. Valve 450 is conically shaped and issecured to vascular device 400 by various techniques such as by beingmolded onto the frame or sewn onto the frame. A pair of elongatedsupports 455 extends from the device into the valve 450 which spread toclose the valve and move inwardly to open the valve. The valve 450 isshown attached to the distal end to extend downstream of the device 400,with respect to blood flow. The valve 450 is shown in the open positionin the figures and would collapse to a closed position by spreading ofthe supports 455, operating like a duckbill valve.

[0150] As an alternative, the supports 455 are not provided and thevalve 450 functions in a similar manner described below with respect tothe other conical valves, e.g. valve 500.

[0151] A reinforcement ring as described below could also optionally beprovided. Valve 450 can be multi-layered, with an outer layer 452composed of one material and an inner layer 454 composed of anothermaterial as shown in FIG. 37A. Possible valve materials are discussedbelow

[0152] It should be appreciated that the vessel engaging members 451 canextend substantially perpendicular as shown in FIG. 36A, or can extendat an angle as described above with respect to FIG. 9B. (See vesselengaging members 451′ of FIG. 36B). Also, although the vessel engagingmembers of FIG. 35A are slightly longer and are bent at a differentregion than the device of FIG. 9A, it should be understood that thedevice of FIG. 9A can be provided with valve 450 or any of the othervalve configurations described herein.

[0153] Turning now to FIGS. 38-47, the vascular device, since it isshown schematically for ease of reference, will be referred to in eachof the drawings by reference letter “D”, it being understood thatpreferably vascular device 100 is utilized, although device 10 and othersupport structures could alternatively be used.

[0154] With reference first to FIGS. 38A and 38B, valve 500 is conicalin shape and has an open proximal end 504 and an open distal end 502.This conical shape results in backflow of blood causing the valve toclose. When the valve 500 is in the position of FIG. 38A, distal openingfaces towards and can press against the vessel wall to prevent flowthrough the valve 500. The force of the blood during systole straightensthe distal end 502 to the position of FIG. 38B to allow blood flowtherethrough. Reinforcement ring 506 helps to maintain the valve 500 inthe open position. As shown, valve 500 extends distally of the device Dso it is positioned downstream with respect to blood flow of the device.

[0155]FIGS. 39A and 39B illustrate a variation to the valveconfiguration of FIG. 38 in that it is similar to valve 500 except thatthe valve 520 is attached to a proximal end E of the vascular device D.Valve 520 is attached at points E1, E2, etc. around the circumferenceand extends upwardly through a central portion of the device “D”.Reinforcement ring 526 functions to help maintain the valve 520 in theopen position of FIG. 39B. FIG. 39A shows the valve 520 in the closedposition and FIG. 39B illustrates the valve in the open position toenable blood flow therethrough. In both positions, the valve extendswithin vascular device D.

[0156] In the embodiment of FIG. 40, the valve 550 is attached to thedistal end of vascular device D and has a plurality of leaflets orpetals 552 arranged circumferentially thereabout. The leaflets foldinwardly towards each other in the closed position of FIG. 40A toprevent blood flow. The pressure of the blood during systole forces theleaflets apart to the open position as shown in FIG. 40B.

[0157] In the embodiment of FIGS. 41A and 41B, valve 560 is conicallyshaped like the valves of FIGS. 38 and 39, but is offset from thecentral longitudinal axis of vascular device D. Additionally, eccentricvalve 560 differs from valves 500 and 520 in that it has a plurality ofslits 562 at a proximal portion to enable drainage of blood to reduceblood buildup. That is during the diastole phase, the slits expand tolarger holes as shown in FIG. 41A and the blood draws through the holes.Reinforcement ring 566 functions as described above to help retain thedistal end open.

[0158] A duckbill valve 570 is illustrated in the embodiment of FIGS.42-44. Valve 570 is attached at the distal end of vascular device D andis moved to the open position as shown in FIG. 43 by blood flow toenable passage therethrough. The closed position of the valve isillustrated in FIGS. 42 and 44. The proximal region of valve 570 isslightly tapered. As with any of the foregoing valves, valve 570 can beattached at the proximal end, distal end, or intermediate portion of thevascular device.

[0159] FIGS. 45-47 illustrate steps for placement of the vascular deviceof the present invention. FIG. 45 shows placement in the popliteal vein“P” and the femoral vein “F” of the vascular device of FIG. 41 by way ofexample, it being understood that any of the vascular devices with anyof the valve configurations can be placed in a similar fashion.Placement of two vascular devices is shown, although only one vasculardevice D (shown schematically) or more than two can be utilized. In FIG.46A, the vascular device and valve 560 are introduced through introducersheath 600 in a collapsed position. The device is retained within adelivery catheter 604. After introduction of the catheter 604 throughthe introducer sheath 600 to the surgical site, the pusher 606 pushesthe device to the end of the catheter 604, is then retracted, followedby retraction of the catheter 604, thereby releasing the device andallowing it to expand to the memorized configuration as shown in FIG.46C for retention in the vein. Alternatively, the pusher can be used tofully advance the device from the catheter 604.

[0160] If it is desired to reposition the device, grasper 610 withindelivery catheter 604 is inserted through the introducer sheath 602. Theprongs or fingers 612 are advanced from the outer tube 614 of grasper610, or the outer tube 614 is moved proximally, to expose the prongs612. The outer tube 614 is then advanced slightly to slightly clinch theprongs 612 so the prongs 612 can grasp the vascular device D and pull itto a more proximal position as shown in FIG. 47C. The grasper 610 isthen removed. Note valve 560 is shown in the open position in FIGS.47A-47C.

[0161] In the embodiment of FIGS. 48-49, valve 700 is in the form of aduckbill valve similar to FIGS. 42-44, except the valve is reinforcedwith metal wires or struts 701. The vascular device is shown in the formof a covered stent 702, with the metal stent 703 embedded in the graftmaterial 704. The valve can include blood drainage slits 706 as shown.

Replacement Valve

[0162] The present invention also contemplates in another aspect use ofthe various valve configurations as replacement valves without the useof a vascular device which brings the walls radially inwardly. Thepatient's valve can be removed or alternatively left in place and thereplacement valve of the present invention placed upstream or downstreamof the patient's valve. In such applications, the valve is attached to asupport structure, such as a shape memory stent, and is maintained in anopen position within the vessel to retain the valve. FIGS. 50 and 51shown an example of a type of support structure for holding the valve.

[0163] More specifically, in the embodiment of FIGS. 50 and 51, insteadof a metal framework, the valve 750 is attached to a rolled upcylindrical ring or metal band 752. The ring 752 can be made of shapememory material with its memorized position being an expanded positionof FIGS. 50 and 51. The valve 750 is similar to valve 500 of FIG. 38A,except it has a larger reinforcement ring 754, and is cylindricalinstead of conical in configuration.

[0164] In the embodiment of FIGS. 52-54, the valve 800 has a pluralityof drainage holes 802 which function in a similar manner as drainageslits 562 of valve 560 of FIGS. 38-39. The overlapping cylindricalsupport member 806 is shown in the contracted delivery position in FIG.54B and in the expanded position in FIG. 54A. Valve 800 islongitudinally offset with respect to cylindrical member 806.

[0165] In the embodiment of FIG. 55, valve 850 is in the form of aduckbill valve and extends from cylindrical support member 856.

[0166] It should be appreciated that the valves 850, 800 and 750 can beused with any of the vascular devices described above. Conversely, anyof the foregoing valves can be used with cylindrical supports 752, 806.Also, the valves can be attached at the proximal end, distal end, orintermediate the proximal and distal ends of the vascular devices.

[0167] The foregoing valves can be attached to the vascular devices, theframework structures and the cylinders, by sewing, molding or othertechniques. The valves can be composed of a variety of materials such asPET, PTFE, polycarbonate polyurethane, swine intestinal submucosa,collagen and other biomaterials. The valve and/or the vascular devicesurface can optionally be coated with anti-platelet oranti-thrombin/anti-clotting materials, 2 b/ 2 a coating, receptors,heparin coating, endothelial cell coating, etc.

[0168] While the above description contains many specifics, thosespecifics should not be construed, as limitations on the scope of thedisclosure, but merely as exemplifications of preferred embodimentsthereof. For example, instead of a balloon to expand the device to itssecond expanded diameter/condition, a mechanical means such as anexpandable wire frame can be utilized. Also, instead of moving thesheath to expose the vascular device, the catheter can be advanced withrespect to the sheath or both the catheter and sheath can move relativeto each other in opposite directions. Those skilled in the art willenvision many other possible variations that are within the scope andspirit of the disclosure as defined by the claims appended hereto.

What is claimed is:
 1. A vascular device comprising a plurality ofvessel engaging members and a valve, the device movable from a collapsedinsertion position having a first diameter to a second expanded positionhaving a second diameter larger than the first diameter, the pluralityof vessel engaging members extending outwardly from the device forsecurely engaging the internal wall of a vessel upon expansion of thedevice to the second expanded position, the vessel engaging memberspulling the internal wall of the vessel radially inwardly upon movementof the device from the second expanded position toward a first expandedposition having a third diameter, the third diameter being greater thanthe first diameter and less than the second diameter, and in the firstexpanded position the valve movable between an open position to allowblood flow therethrough to a closed position to prevent blood flow. 2.The vascular device of claim 1, wherein the device is composed of shapememory material and the first expanded position substantiallycorresponds to the memorized position of the device, and the device isexpanded to the second expanded position by an expandable devicepositioned within the device.
 3. The vascular device of claim 1, whereinthe device is composed of shape memory material and is initially movablefrom the collapsed position to the first expanded position in responseto exposure to body temperature, and is subsequently moved from thefirst expanded position to the second expanded position by an expandablemember.
 4. The vascular device of claim 1, wherein the device iscomposed of shape memory material and is movable from the collapsedposition to the second expanded position by the substantial simultaneousexposure to body temperature and expansion by an expandable member. 5.The vascular device of claim 1, wherein the valve is substantiallyconical in shape.
 6. The vascular device of claim 5, wherein alongitudinal axis of the valve is offset from a longitudinal axis of thevascular device.
 7. The vascular device of claim 1, wherein the valveincludes a plurality of blood drainage openings extending through a sidewall.
 8. The vascular device of claim 1, wherein the valve has aproximal opening and a distal opening, and a reinforcement ring adjacentthe distal opening.
 9. The vascular device of claim 1, wherein the valveis attached to a distal end of the vascular device to extend downstreamof the device when positioned within a patient.
 10. The vascular deviceof claim 1, wherein the valve is attached to a proximal end of thevascular device to extend within a central portion of the device whenpositioned within a patient.
 11. The vascular device of claim 1, whereinthe valve is a duckbill valve configuration.
 12. A vascular systemcomprising: a balloon catheter having an elongated shaft and anexpandable balloon; a vascular device mounted over the expandableballoon having a first position and a second expanded position, thevascular device expandable to an expanded position to engage the vesselwalls and returnable substantially to the first position to bring thewalls radially inwardly; and a valve connected to the vascular deviceand movable between a closed position to prevent blood flow and an openposition to allow blood flow therethrough.
 13. The vascular system ofclaim 12, wherein the vascular device is comprises shape memory materialand is expandable first to a memorized condition in response to exposureto body temperature and subsequently expanded to the expanded positionby inflation of the balloon.
 14. The vascular system of claim 12,wherein the vascular device is expandable to the expanded position asthe device is substantially simultaneously exposed to body temperatureand the balloon is inflated.
 15. The vascular system of claim 12,wherein the device is comprises stainless steel and the balloon expandsthe device below its elastic limit to allow the device to return to thefirst position.
 16. The vascular system of claim 12, wherein thevascular device is releasably connected to the balloon.
 17. The vasculardevice of claim 12, wherein the valve includes a plurality of blooddrainage openings extending through a side wall.
 18. A method fortreating venous valve insufficiency comprising: inserting a deliverydevice and a vascular device having a replacement valve into a targetvessel adjacent the region of the removed portion of leaflets; deployingthe vascular device to an enlarged diameter to securely engage theinternal wall of the vessel; and reducing the diameter of the vasculardevice to move the vessel wall radially inwardly to reduce dilation ofthe vessel and implant the replacement valve.
 19. The method of claim18, further comprising the step of removing at least a portion of veinvalve leaflets of a patient prior to deploying the vascular device. 20.The method of claim 18, further comprising the step of deploying thevascular device to a first expanded diameter prior to deploying thedevice to the enlarged diameter, the step of deploying the vasculardevice to a first diameter including the step of exposing the vasculardevice from a sheath of the delivery device to enable the vasculardevice to return a shape memorized configuration in response to beingwarmed by body temperature, the first expanded diameter being less thanthe enlarged diameter, and the step of reducing the diameter of thevascular device returns the device to a diameter substantially equal tothe first expanded diameter.
 21. The method of claim 18, wherein thestep of the deploying the vascular device to an enlarged diameterincludes the step of inflating a balloon positioned within the device,the step of inflating the balloon enabling a plurality of vesselengaging members of the vascular device to penetrate and retain thevessel wall.
 22. The method of claim 18, wherein the vascular device iscomposed of stainless steel and the step of deploying the vasculardevice expands the device below its elastic limit to enable it to returnto its reduced diameter when the balloon is deflated.
 23. The method ofclaim 18, wherein the delivery device is inserted through the jugularvein or the femoral vein into the popliteal vein or the saphenous vein.24. The method of claim 18, wherein the step of deploying the vasculardevice to an enlarged diameter comprises releasing the vascular devicefrom the delivery device to enable it to return to a shape memorizedcondition and substantially simultaneously inflating a balloon.
 25. Areplacement valve comprising a support structure and a valve attachedthereto, the valve being substantially conical in configuration andhaving a proximal end, a distal end, and a proximal and distal opening,the distal opening facing away from the longitudinal axis when the valveis in the closed position and aligned with the longitudinal axis whenthe valve is in the open position.
 26. The replacement valve of claim25, wherein the valve is attached to a proximal end of the supportstructure.
 27. The replacement valve of claim 25, wherein the valve isattached to a distal end of the support structure.
 28. The replacementvalve of claim 25, wherein the valve is offset with respect to thelongitudinal axis of the support structure.
 29. The replacement valve ofclaim 25, wherein the valve includes a plurality of drainage openingformed in a side wall adjacent the proximal end.
 30. The replacementvalve of claim 25, wherein the support structure is in the form of acylinder.